Therapy system

ABSTRACT

A therapy system providing exercise, massage, and medication. The system includes a portable, wearable exercise device with provisions for resistance during range of motion exercises. The system also offers metrics, diagnostics, remote monitoring, massage therapy, and controlled delivery of medication. The therapy system automatically provides information that is useful for determining recommendations for enhancing therapy.

This is a Continuation-in-Part of U.S. patent application Ser. No.10/212,485, entitled HAND REHABILITATION GLOVE, of Brassil, et al.,filed Aug. 8, 2002 (which is currently pending and will be abandoned),which is a Divisional of U.S. patent application Ser. No. 09/475,793,entitled HAND REHABILITATION GLOVE, of Brassil, et al., filed Dec. 30,1999, (which issued as U.S. Pat. No. 6,454,681) which is aContinuation-in-Part of U.S. patent application Ser. No. 09/197,035,entitled HAND REHABILITATION GLOVE, of Brassil, filed Nov. 29, 1998,which claims priority from U.S. Provisional Application 60/070,380,entitled HAND REHABILITATION GLOVE, of Brassil, filed Jan. 5, 1998, allof which are incorporated, in their entireties, herein by reference.

BACKGROUND OF THE INVENTION

The present invention relates to therapy systems. As the baby boomersage, healthcare providers and financing providers, such as Medicare andprivate insurers, will be stressed by high demand, relative to supply.Insurance is well known in the art, with managed care strategies thatinclude insurers in medical decisions, but healthcare costs have grownto 16% of GDP, with projections for 20% by 2015. Nationalized solutionsresult in rationing, waiting lines, and overcrowding. Supply-centeredsolutions would offer more doctors, nurses, and clinics, but a massiveexpansion could impact the quality of care, disrupt establishedproviders, and discourage investors. Taxes can be raised to coverspending, but estimates show Medicare's total unfunded liability to beover $70 trillion. There is an unmet need for systems that will help theMedicare trustees grow and preserve the fund. Post-process audits andinvestigations for misbehaving members, are well known in the art. But,there is an unmet need for feedback early in the process to help thetrustees find members of the Medicare system who promote safety andsavings; to calculate and offer them early incentives. This systemautomatically generates feedback useful for determining earlyincentives.

Arthritis is the nation's leading cause of disability, with estimatesshowing that one in five adults in the nation are affected by arthritis.The limited supply of providers helping arthritis patients will bestressed by increasing demand as the baby boomers age. This systemoffers savings, balanced neuromuscular development, massage, controlleddelivery of medication, and feedback, from the comfort of the patient'shome.

SUMMARY

Disclosed is an exercise and therapy system. It provides resistanceexercise, massage, and medication. It provides means for monitoring,delivering, and controlling therapy. It generates therapy informationthat is useful for patients and providers.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and other aspects, features and advantages of the presentinvention will be more apparent from the following more particulardescription, along with the following drawings wherein:

FIG. 1 is a view of an exercise and therapy device in accordance withone embodiment of the present invention;

FIG. 2 is a view of an embodiment delivering medication;

FIG. 3 is a view of an embodiment delivering pressurized medication;

FIG. 4 is a view of an embodiment with an encapsulant or pocket;

FIG. 5 is a view of an embodiment with an array of electrodes;

FIG. 6 is a view of an embodiment which includes monitoring means;

FIG. 7A is a view of another embodiment of the device of FIG. 6including multiple chambers within the compressible substance;

FIG. 7B is a view of another embodiment of the device of FIG. 7A whereinthe multiple chambers of the compressible substance are separated bywalls;

FIG. 8 is a view of the embodiment of the device of FIG. 7A andincluding a displacement transducer module of the embodiment of FIG. 6;

FIGS. 9A and 9B are views of the device of FIG. 6 illustrating thedisplacement transducer module and line configurations;

FIG. 10 is a block diagram of one embodiment of the therapy system.

FIG. 11 is a functional block diagram of an embodiment of a therapysystem.

FIG. 12 a view of an embodiment of the compressor/pressure transducermodule.

FIG. 13 is a flow chart illustrating the steps for generatinginformation for facilitating therapy.

FIG. 14 is a view an embodiment of means for monitoring the therapy.

FIG. 15 is a view of an embodiment of a display for monitoring thetherapy.

FIG. 16 is a view of an embodiment of a display for monitoring thetherapy.

Corresponding reference characters indicate corresponding componentsthroughout the several views of the drawings.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The following description of the presently contemplated best mode ofpracticing the invention is not to be read in a limiting sense, but ismade merely for the purpose of describing the general principles of theinvention.

Referring now in detail to the drawings, in which like numerals indicatecorresponding parts throughout the several views, FIG. 1 illustrates atherapy device embodied preferably as a glove 1. Included are acompressible substance 3, a proximate (to the compressible substance)portion 4, finger portions 5, a distal (to the compressible substance)portion 6, and elastic members 2. Each elastic member 2 spans or extendsfrom glove 1 to the compressible substance 3. The compressible substance3 provides resistance during flexion, and the elastic members 2 provideresistance during extension. Each elastic member 2 is coupled to thecompressible substance 3 and then spans to, and attaches to, the glove1. In another embodiment, the elastic members may be attached to theproximate portion 4, through “slits” 13 formed in the compressiblesubstance 3 which the elastic members 2 pass through and then span toand attach to the distal portion 6. Such slits 13 run through thecompressible substance 3. In FIG. 1, the dashed line 14 represents anelastic member 2 extended through the compressible substance 3 andattached to the proximate portion 4 directly. Note that only one of theslits 13 is shown, although multiple elastic members 2 could extendthrough slits in the compressible substance 3. The elastic members 2 maybe attached along an edge 8 of the glove 1, between the proximateportion 4 and the distal portion 6. Additionally, the subject matterdescribed herein is related to Canadien Patent Application Serial No.2,282,072, entitled HAND REHABILITATION GLOVE, of Brassil, filed Sep.10, 1999, which is incorporated herein by reference. It is to beappreciated that a skilled artist could easily alter or modify apreferred embodiment without departing from the spirit of the invention.

Referring next to FIG. 2, a medication delivery device, preferably adisposable glove, is shown with a cutaway window view. The medicationdelivery device 202 includes an inner surface 210 and an outer surface208. The interior surface 210 of the medication delivery device 202 iscoated with medication 212. The system provides a massaging effect thatwill enhance medication 212 absorption into the skin. During extension,the elastic members 2, pull the medication delivery device 202 closer tothe wearer's skin, whereby massaging the medication 212 pressed betweenthe medication delivery device 202, and the wearer's skin. Duringflexion, the compressible substance 3, pushes the medication deliverydevice 202 closer to the wearer's skin, whereby massaging the medication212 pressed between the medication delivery device 202, and the wearer'sskin. Medications or supplements with transdermal or transcellularcarriers may be used to synergistically enhance therapy. Examples ofsuch medications or supplements are glucosomine and chrondroitinsulfate, which have been found to be helpful in treating osteoarthritis,and are described in pages 29-52 of “The Arthritis Cure” by Theodosakis,Adderly and Fox, 1997, which is incorporated herein by reference.Research studies have shown that glucosomine and chrondroitin are safeand effective, but only a limited percentage is delivered to the targetsite when ingested orally. These medications 212 may also includecarriers or penetration enhancing agents, such as those shown in U.S.Pat. No. 4,362,737, issued Dec. 7, 1982 to Schafer, and U.S. Pat. No.4,405,616 issued Sep. 20, 1983 to Rajadhyaksha, both of which areincorporated herein by reference. Thus, the system provides exercise,massage, and controlled delivery of medication 212 to the target site,which can be controlled for example, by the number of extension andflexion repetitions. Since the system delivers medication directly tothe target site, the patient doesn't need to purchase as much medicationas would be required for an oral medication to reach the sameconcentration at the target site. The system can help patients andproviders avoid the safety risks of uncontrollable oral medications,which travel through the digestive system, mix with foods, drinks, andother medications; filter into the circulatory system, and affect manyother off-target sites throughout the body. The safety hazards tooff-target body sites are well known in the art, and are often admittedto within or on the medication package, so the foreknown safety risksand resulting costs (including the costs of legal service providers)must be calculated by malpractice, business, and health financingprovider underwriters, if the financing provider entity is going toattract and retain investors, which leads to a multiplier effectincreasing the cost of care. If uncontrollable oral medication must beused, the system may still be able to help draw medication to the targetsite, because resistance exercise, tissue massage, and leeching (seeFIG. 5) can enhance circulation at the target site. The system alsooffers advantages in the way that medication 212 is dispensed. Forexamnple, medication dispensed as a bottle of 100 uncontrollable pills,allows many more unsafe permutations than a single disposable device202, coated with site-specific medication 212. Medication 214 may alsobe formed within the body of the medication delivery device 202,especially if the medication delivery device 202 is formed with asponge-like material. The inner surface 210 and body of the medicationdelivery device 202 could be formed with a sponge-like material, whilethe outer surface 214 could be formed with a less porous material.Advantageously, the medication delivery device 202 operating underrepetitious compression from the compressible substance 3 and tensionfrom the elastic members 2, dispenses and delivers medication 214, tothe target site.

Referring next to FIG. 3, a medication delivery device, preferably aglove, is shown with a cutaway window view. The medication deliverydevice 302 includes an inner surface 310 and an outer surface 308. Inone embodiment, the inner surface 310 may contain a medication 312. Inanother embodiment, a canister 314 provides medication under pressure,through a connecting tube 316. The canister 314 may be pressurized, ormay be connected to a compressor/pressure transducer module (see FIG.12). These techniques and equipment for accomplishing the techniques aredescribed, for example, in U.S. Pat. No. 5,688,233, issued Nov. 18, 1997to Hofmann, et al. entitled “ELECTROINCORPORATION ENHANCED TRANSDERMALDELIVERY OF MOLECULES”; which is incorporated herein by reference.Advantageously, the system delivers pressurized medication directly tothe target site. For example, the known safety risks of ear or lungdamage from a whole-body hyperbaric oxygen chamber could be avoided bypumping concentrated oxygen directly to the target site. By reversingthe pressure, a leeching effect can be useful for removing waste,enhancing circulation, or reducing swelling. The vacuumed effluent canbe retained in a canister 314, and analyzed by researchers. Suchresearch and equipment for conducting the research are commerciallyavailable from Finnegan Corporation of San Jose, Calif. which providesmass spectrometer technology capable of identifying the exact molecularor particulate breakdown of the contents of the canister 314. So, onegroup of patients could ingest an oral medication, and another groupcould use the medication delivery device 302 to deliver a similarmedication directly to the target site. After a predetermined timeperiod, a fresh disposable device 302, operating in vacuum mode,provides effluent from the target site which can be retained in acanister 314, providing researchers with evidence useful for comparingconcentration levels of medications or other markers at the target site.Such feedback can be useful for advising patients and providers who needto compare the safety, cost, control, and effectiveness of medicationsand their delivery systems. Such information is especially useful forfinancing providers, as input into automated risk scoring andunderwriting systems, for determining early incentives.

Referring next to FIG. 4, a sectional view of a glove embodiment 402 isshown. This embodiment provides an encapsulant 404 or pocket, withinwhich the compressible substance 3 is positioned. Additionally, theencapsulant 404 could have a cover flap 406 that folds or seals over thecompressible substance 3. The compressible substance 3 under pressurefrom flexion exercise, may force the cover flap 406 to become separatedor unsealed from the glove 402, thus dispensing and deliveringmedication 408 under pressure emanating from the deflating compressiblesubstance 3.

Referring next to FIG. 5, an exploded view of a glove embodiment 502with an array of electrodes 506 is shown. Electrodes 506 for providing alow level pulsed electric field, are coupled to the interior surface 504of the glove 502. The pulsed electric field delivers materials, such asmedication 508 and supplements, through the skin; to the target site.The electrodes 506 are connected to the signal generator 515 (see FIG.10) by a cable 512. A fluid medium carrying molecules or medication maybe supplied from the fluid medium source 514, which is coupled to theglove 502 by a tube 510 which may include a pump (see FIGS. 10 and 12).Such techniques are known in the art and are referred to as“electroporation” or “electroincorporation”. These techniques andequipment for accomplishing the techniques are described in U.S. Pat.No. 5,688,233, issued Nov. 18, 1997 to Hofmann, et al. entitled“ELECTROINCORPORATION ENHANCED TRANSDERMAL DELIVERY OF MOLECULES”; whichis incorporated herein by reference. The pneumatics/fluidics, sensors,and controller modules provide monitoring and control of the pressureand electrical pulses (explained below). Thus, the system provides meansfor delivering medication, including means for monitoring andcontrolling its delivery. Operating in reverse or vacuum mode, thesystem provides means for controlling the reduction of swelling orremoving medication, with electroporation and transdermal ortranscellular carrier means.

FIG. 6 illustrates an embodiment providing means for monitoring therapy.Shown is a monitored therapy system device 600, embodied as a glove 602,with a proximate portion 604, finger portions 606, distal portion 608,fingernail portion 610, wrist portion 612, a compressible substance 614that has a chamber 616 located within the compressible substance 614, adisplacement transducer module 618, a compressor/pressure transducermodule 620, a thermal transducer 622, lines 624, line guides 626, anchor628, fill tube 630, output means 632, and a computer interface 634. Thisembodiment offers transducers to determine estimates of performance,such as force exerted on the compressible substance 614 (using thecompressor/pressure transducer module 620), range of motion (using thedisplacement transducer module 618), heat generated (using the thermaltransducer 622), number of repetitions, or velocity. It features atransducer module 618, with lines 624 extending therefrom. The lines areguided through line guides 626 and are anchored at the anchor 628, whichis located distally at the fingernail portion 610. Force is monitored bya compressor/pressure transducer module 620 affixed at the inside wristportion 612. The fill tube 630 extends from the compressor/pressuretransducer module 620 and into the compressible substance 614 to thechamber 616 within the compressible substance 614. In other embodiments,modules may be swapped out or relocated. For example, the fill tube maybe coupled directly to the glove 602 (see FIGS. 3 and 5). The elasticmembers (not shown) are also present. Furthermore, the displacementtransducer module 618 and the compressor/pressure transducer module 620link to a computer. This embodiment illustrates an output means 632connected to a computer interface 634 as means for linking to a computeror controller, as part of a monitored therapy system.

In operation, the monitored therapy system, quantifies motion, force,work done, as well as the number and speed of repetitions performed. Inthis embodiment, the compressible substance 614 has a chamber 616 insidewhich is used to for measuring pressure resulting from the force asapplied onto the compressible substance 614. The chamber 616 is filledwith air, a gas, a fluid or a gel through the fill tube 630 that extendsfrom the compressor/pressure transducer module 620 into the compressiblesubstance 614. The compressor/pressure transducer module 620 istypically controlled by a separate controller. Thus, when pressure isapplied to the compressible substance 614, a portion of the contentwithin the chamber 616 is forced out through the fill tube 630 into thecompressor/pressure transducer module 620. The pressure transducerportion of the compressor/transducer module 620 translates this push ofgas, fluid, or gel into a signal proportional to or representing thepressure or force applied against the compressible substance 614. Thissignal is output using output means 632. Valves may be used at the entryof the fill tube 630 into the chamber 616 to help establish the requiredpressure level within the chamber 616.

The compressor portion of the compressor/pressure transducer module 620is a pneumatic or fluidic component, which uses a compressor or pump.This compressor is a miniature mechanical compressor, such as thosecommercially available from Gast located in Benton Harbor, Mich. or MedoUSA of Hanover Park, Ill. or Sensidyne of Clearwater, Fla., and are usedto inflate the compressible substance to a therapeutic pressure. Thecompressor may be a part of the compressor/pressure transducer module620 as shown or may be a separate unit that is worn on the body of thepatient (e.g. on the patient's belt) or placed nearby the patient andattached to the compressible substance 614 via a tube. The timing andrate at which the compressor inflates or pressurizes the chamber 616within the compressible substance 614 maybe set by a separatecontroller. Alternatively, a squeezable ball, such as used in bloodpressure cuffs, may be used to for inflation, or a miniature tank ofcompressed gas. Furthermore, valves may be used in addition to thecompressor. For example, micro solenoid valves like those used in inkjetprinters or pinch valves like those used in pneumatic systems can beused to control the air or fluid flowing in and out of the chamber 616of the compressible substance 614. Such valves could be open or shut, orpulsed, working in concert with the compressor or pump to control thepressure in the chamber 616 (or chambers) and the rate at which they areinflated or filled. These valves are readily available, such ascommercially available from Lee Company of Westbrook, Conn. or SMC,located in Indianapolis, Ind.

The pressure transducer portion of the compressor/pressure transducermodule 620 is a transducer that produces a signal proportional to thepressure applied to its port, which is proportional to or represents thepressure or force applied by the patient. Typically, the port of thepressure transducer is positioned at the end of the fill tube 630 withinthe compressor/pressure transducer module 620 so that the gas or fluidthat is forced from the chamber 616 of the compressible substance 614.In response to the pressure against the port of the pressure transducer,the pressure transducer outputs a signal that is proportional to orrepresents the pressure inside the chamber 616. Such pressuretransducers are well known in the art and are commercially availablefrom Honeywell located in Minnesota. In this embodiment, thecompressor/pressure transducer module 620 uses output means 632 that islinked to the computer interface 634, which in turn may be linked to acontroller of a therapy system. Medication (not shown) may be containedin various locations throughout the system.

The displacement transducer module 618 provides the means for measuringmotion or the distance traveled during extension and flexion. Oneembodiment of a displacement transducer module 618 is a rotary encodersystem. Within the displacement transducer module 618, a shaft of therotary encoder is coupled to a spool or roller carrying the line 624.Ideally, the spool or roller is spring loaded so that the line 624 ispulled tight from the anchor 628 to the spool of the displacementtransducer module 618. The distal end of the lines 624 are attached toan anchor 628. The lines 624 pass through respective line guides 626.Alternatively, the lines 624 may pass through a flexible protectivetubing so as to protect the lines during use.

In use, during flexion, the lines 624 are drawn from the spool causingthe rotary encoder to transmit electrical pulses whose number is inproportion to the flexing and movement. The stiffness of the line 624returning through the line guides 626, or a light-force spring returnmechanism in the spool or roller would return the line 624 back onto thespool or across the roller during extension, providing extension andflexion displacement data. Thus, the rotary encoder can determine themagnitude of the movement, so that a complete range of movement whileopening and closing the hand may be modeled. The displacement transducermodule 618 will output a signal over output means 632 to the computerinterface 634 that is proportional to or represents the displacement.

Alternative means for monitoring displacement include the use of straingauge transducers. These sensors produce an electrical signal inproportion to motion. They work on a variety principles: piezo electric,electro mechanical (like a condenser microphone), accelerometer,goniometer, and variable resistance strain gauge. These transducers, andtheir detector circuits, are readily available in scientific materialscatalogs like Cole Parmer, located in Vernon Hills, Ill. Other examplesof monitoring means and wearing means, are shown in U.S. Pat. No.5,280,265 issued Jan. 18, 1994 to Kramer, et al., entitled “STRAINSENSING GONIOMETERS, SYSTEMS AND RECOGNITION ALGORITHMS”; in U.S. Pat.No. 4,414,537, issued Nov. 8, 1983 to Grimes entitled “DIGITAL DATAENTRY GLOVE INTERFACE DEVICE”; and in U.S. Pat. No. 4,542,291, issuedSep. 17, 1995 to Zimmerman entitled “OPTICAL FLEX SENSOR”, all of whichare incorporated herein by reference. The preferred means for monitoringmotion are not meant to be limiting, as those skilled in the art canmodify a preferred embodiment without departing from the scope or spiritof the invention.

Additionally, a thermal transducer 622 is positioned within themonitored therapy system device 600. The thermal sensor, measures thetemperature change during exercise, providing a calorimetric estimate ofwork. This feedback can be used as simple and expensive way to measurethe progress, and enhance a patient's therapy.

Thus, monitoring means can provide outputs that represent force,temperature, and motion during exercise. These output signals may alsobe used to determine the number and speed of repetitions. Additionally,the system includes means for linking to a computer system that may beused to display and store the measurements and/or control the pressurewithin the chamber 616 of the compressible substance 614. A therapyprovider can monitor the results of therapy sessions, and use theperformance feedback to make recommendations for enhancing the therapy.

Referring next to FIG. 7A, another glove embodiment is shown includingmultiple chambers within the compressible substance. Shown are amonitored therapy system device 700 a proximate portion 702, wristportion 708, finger portions 704 and distal portion 706, thecompressor/pressure transducer module 710, the compressible substance712 including chambers 714 and fill tubes 716 extending through a mainfill tube 718. Also shown are the elastic members 720. This embodimentprovides a chamber within the compressible substance 712 that is dividedinto separate chambers 714. Similarly, instead of one fill tube, thereis a separate fill tube 716 for each of the chambers 714. Each fill tube716 extends through the compressible substance 712 into thecompressor/pressure transducer module 710 via a main fill tube 718.Furthermore, the compressor/pressure transducer module 710 actuallycontains separate pressure transducers one for each chamber 714. Thepatient or therapist may adjust the pressure within each of therespective chambers 714. By adjusting the pressure, the delivery ofmedication (not shown), and extraction of waste, can be controlled.

Referring next to FIG. 7B, is a view of another embodiment whereinmultiple chambers of the compressible substance are separated by walls715. This embodiment includes walls 715 that separate the chambers 714within the compressible substance 712. As can be seen, walls 715 aremolded in between the individual chambers 714 of the compressiblesubstance 712. Such walls 715 are slightly more rigid than the remainingmaterial of the compressible substance 712 so that pressure applied toone chamber 714 will not in effect apply pressure to an adjacentchamber. Therefore, the majority of the pressure will be channeled suchthat the fluids within the individual chambers 714 will be forced out ofthe chamber 714 into the fill tubes 716, and not expand sideways intoadjacent chambers. The walls 715 should not be so rigid that they do notallow the compressible substance to adequately be compressed orsqueezed. These walls 715 may be molded as described above while thecompressible substance 712 is being formed. Alternatively, the walls 715could be made to be rigid; thus, these rigid walls would almostcompletely eliminate pressure from an adjacent chamber from having aneffect on a given chamber's pressure reading. As another alternative,the walls themselves may be the elastic members 720 that extend throughslits in the compressible substance 712. These slits and elastic membersare described with reference to FIG. 1. Thus, the elastic members 720would extend through the compressible substance 712 and attach to theproximate portion of the glove, while at the same time forming wallsbetween chambers 714 of the compressible substance 712.

Referring next to FIG. 8, is a monitored therapy system device includinga displacement transducer module. Shown is a monitored therapy systemdevice 800 embodied as a glove having a back portion 802, a proximateportion, distal portion 804, fingernail area 806, and wrist area 808.Also shown are the compressible substance 810 including multiplechambers 812, and fill tubes 814 within a main fill tube 816, thecompressor/pressure transducer module 820, displacement transducermodule 822, lines 824, line guides 826, anchor 828, and the elasticmembers 830. The individual chambers 812 within the compressiblesubstance are better illustrated including their positioning within thecompressible substance in FIG. 8. The fluid within each chamber 812 isforced through a respective fill tube 814 to a respective pressuretransducer within the compressor/pressure transducer module 820 via themain fill tube 816. It is also noted that the compressor may not bewithin the compressor/pressure transducer module 820, but may be locatedelsewhere on the body of the patient or located proximate to thepatient. Also, the entire compressor pressure transducer module 820could be located separately and attached by the fill tube 816. Thus, thecompressor is coupled to the fill tubes 814 through the pressuretransducer. For example, the compressor and the pressure transducer areboth coupled to the fill tubes, but a valve or similar functioningdevice can cut off the compressor from the fill tube when desired.Furthermore, there are multiple pressure transducers as a part of thecompressor/pressure transducer module 820. Medication (not shown) may bepositioned in various locations within the system. Medication could becontained and pressurized in one chamber 812, while waste or effluentcould be vacuumed into and captured in another chamber.

Referring next to FIGS. 9A and 9B, two different embodiments are shownfor the displacement transducer modules and the structures used tomeasure the displacement. Shown is a monitored therapy system device 900embodied as a glove including the back portion 902, finger portion 904,fingernail portion 906, lines 908, line guides 910, anchors 912, anddisplacement transducer modules 914, 914′ and 915 are output means 916.As shown and also as described above, the lines 908 are a low stretch,monofilament or wound thread that extends from the displacementtransducer module 914 to the anchor 912 at the distal portion 906. Thelines 908 are threaded or fed through line guides 910 that have holestherein or a channel formed at the exterior surface (alternatively, theline guides 910 may be flexible hollow tubes). The lines 908 are woundonto a spring loaded spool or a spring tensioned roller such that thelines 908 are held relatively tightly from the anchor 912 at the distalend of the displacement measuring system and the displacementtransducer. The displacement transducer module 914 shown in FIG. 9Acontains multiple displacement transducers and a single output 916 whichincludes a computer interface (not shown). The displacement transducermodule shown in FIG. 9B is broken into two separate modules, firstdisplacement transducer module 914′ and second displacement transducermodule 915. Again, output means 916 is shown, which is linked to acomputer interface.

Referring next to FIG. 10, is a block diagram of the monitored therapysystem 1000. This embodiment of the monitored therapy system 1000includes the therapy device 1010, patient 1020,sensing/communicating/controlling equipment (“SCCE”) 1030, serviceprovider 1040, product provider 1050, financing provider 1060, andcommunications provider 1070. The financing provider 1060 includesMedicare 1062 but other embodiments could include various financingproviders 1060 such as banks, lenders, or insurance entities such ashealth, malpractice, business, medicaid, disability, workerscompensation, long term care, etc., which are well known in the art. Thefinancing provider 1060 provides capital for the purchase of products orservices that a member, usually a patient 1020, service provider 1040,or product provider 1050, cannot afford to, chooses no to, or isotherwise unable to, afford outright. Occasionally, financing providers1060 such as malpractice or business insurance firms, provide capital tosettle disputes between members. The financing provider 1060 has thefunctions of attracting members, protecting and growing their fund,determining and minimizing waste, safety risks, and health risks (whichwill deplete the fund), and providing capital. Thesensing/communicating/controlling equipment (“SCCE”) 1030 include acontrol panel 1037, feedback controller 1036, and transducers 1031. Thecontrol panel 1037 includes a keyboard 1038 and display 1039. Thetransducers include motion 1032, force 1033, sound 1034, and temperature1035. The therapy device 1010 includes an encapsulant 1011, compressiblesubstance 1012, pneumatics/fluidics 1014, elastic members 1016,medication 1017, electrodes 1018, and preferably, a glove 1019. Theservice provider 1040 includes diagnostics 1041, therapy 1042, andadvice 1043. Advice providers 1043 includes training 1044, research1045, and advertising 1046. The product provider 1050 includespharmaceutical 1052 and equipment 1054. The communications provider 1070includes well known means for computing and communicating throughout thesystem, allowing data processing and storage to occur at various points.The monitored therapy system 1000 automatically provides informationthat is useful for determining members' needs, helping providers meetmembers' needs in a targeted manner. For example, the advertisingprovider 1046 can provide targeted ads (not shown) promoting productproviders 1050, or service providers 1040 to specific patients 1020 (orother provider members) based on automatically generated target-specificinformation, such as a diagnosis code, thereby avoiding the cost ofexpensive off-target broadcast ads. Lower advertising costs can generatea multiplier effect; decreasing prices throughout the system 1000; notjust for the patients 1020, but also for providers. Advertisingexpenditure information is readily available from SEC filing,prospectus, annual report, and investor relations documents. Thus, thesystem 1000, offers patients 1020 and financing providers 1060 such asMedicare 1062, information that is useful for limiting spending onunsafe or unrelated items, for example for passthroughs that aren'thealthcare, such as broadcast advertising. Furthermore, targeted advice1043, such as needs based training 1044, related research 1045, andpersonalized advertising 1046, based on information provided by thesystem 1000, is a reasonable way to spend Medicare 1062 funds onpassthroughs, if that advice 1043 meets specific healthcare needs. Thesystem 1000 includes incentives (not shown) that financing providers1060 can award to service providers 1040, product providers 1050, andpatients 1020 who, for example, promote safety, or minimize unnecessarypassthrough spending.

The patient 1020 interacts with a therapy device 1010, that providesflexion resistance exercise, extension resistance, exercise, massage,medication, and medication delivery control. The electrodes 1018 receivesignals from the SCCE 1030 that control the transdermal delivery ofmedication 1017. The pneumatics/fluidics module 1014 may also receivesignals from the SCCE 1030 that control pressure to inflate or deflatethe compressible substance 1012, or deliver or remove medication 1017.In operation, the monitored therapy system 1000 provides means formeasuring the motion, force and work done by the patient. Furthermore,it provides a means for controlling, the pressure resistance of thecompressible substance 1012, and the delivery of medication 1017automatically, so that therapy parameters can be set, monitored, andmaintained automatically by the patient's 1020 or therapy provider's1042 interaction with the SCCE 1030.

In this embodiment, both the patient 1020 and the therapy provider 1042are operators of the SCCE 1030. In other embodiments, it may beadvantageous for a training provider 1044, equipment provider 1054, orpharmaceutical provider 1052 to interact directly or remotely with theSCCE 1030 to help novice users. Both the patient 1020 and the therapyprovider 1042 can set the therapy parameters such as resistancepressure, or range of motion goals, and will review the therapy outcomessuch as joint movement, pressure or force applied, or work done. Overtime, the therapy provider 1042 will adjust the therapy parameters toreflect the best plan of treatment. The therapy provider 1042 mayinteract remotely through the SCCE 1030 to control the therapy device1010, or by making recommendations to the patient 1020 regardingadjustments.

A computer (not shown) could be physically integrated with the SCCE1030, located in its vicinity, or connected via a network link. Itprovides a way for the therapy provider 1042 to adjust parameters andreview treatment, locally and remotely. It stores and organizes therapyparameters and outcomes in a database for archival and ready access. Italso converts outcomes data into a graphical charts displayable on acomputer terminal and printable on paper that ease the interpretation ofthe outcomes data and help the providers make better recommendations.The SCCE 1030 might be a standalone unit, located near the patient 1020,or it might be a miniature battery operated controller that isintegrated, for example as an attachment to the therapy device 1010. TheSCCE 1030 receives and generates signals to and from various sourcesthroughout the system 1000, and contains the algorithms necessary totranslate the signals from the various transducers 1031 into therespective estimations of actual displacement, temperature and force orpressure applied. Such algorithms for translating these conventionalsignals supplied by conventional transducers are well known in the art;thus, no further explanation is required. The SCCE 1030 is also able todetermine the number of repetitions and speed of repetitions, forexample, by comparing the direction of the displacement signals receivedand when the signals “change direction” (indicating a change fromextension to flexion, for example) to a timer or clock. The SCCE 1030also sends control signals to the compressor to set the resistance. TheSCCE 1030 translates the signals from the transducers 1031, andmaintains communications between the therapy device 1010, and its users.It could contain a custom computer, such as a microcomputer or personaldigital assistant, or a common personal computer running commerciallyavailable software, such as National Instruments' Labview. The controlpanel 1037 consists of knobs, buttons and displays 1039 that allow theuser to set therapy parameters and review therapy outcomes. These knobs,buttons and displays are electronically connected to the SCCE's 1030embedded computer. The control panel 1037 may be configured so that thepatient 1020 or therapy provider 1042 can: set the initial and finalpressure resistance level of the compressible substance 1012; set arepetitions counter or therapy timer; set limits and alarms for excesspressure or other abnormal conditions; set control parameters such asPID (proportional, integral, derivative) constants; store parameters forfuture use; and control the power for the SCCE 1030. Additionally, thecontrol panel 1037 may provide a display 1039 indicating real timeindications of pressure, displacement, and work, as well as graphicaldisplays of such measurements. Additionally, the therapy settings may beshown. Such displays may be displayed on a corresponding computer or ona screen or display 1039 of the SCCE 1030 itself depending on theembodiment. The knobs, buttons and displays comprising the control panel1037 are commercially available from many sources as discrete componentsor integrated into control panel assemblies. Displays are widelyavailable in the following forms: LED alphanumeric displays, LCDalphanumeric and graphic displays, electro luminescent and plasmadisplays, and cathode ray tubes.

The SCCE 1030 allows the pressure resistance to be adjustedautomatically in dynamic response to predetermined pressure profiles andsequences, existing pressure in the chamber/s of the compressiblesubstance 1012, motion, and the work being done. The feedback control1036 is a function performed by the SCCE's embedded computer. Itreceives the real-time pressure, displacement, and work measurements,then uses readily available algorithms, such as PID (proportional,integral, derivative) control to send the proper signals to adjust thevalve settings and the compressor (within the pneumatics/fluidics module1014), to maintain the pressure resistance within the chamber/s of thetherapy device 1010 according to the therapy provider's 1042 orpatient's 1020 settings. The feedback controller 1036 contains therapydata storage circuits, parameter storage circuits, and a real time clockthat permit it to operate autonomously.

The SCCE 1030 communicates with the therapy device 1010. It outputssignals to the pneumatic/fluidic module 1014, to control the amount ofpressure that the chambers are inflated to, and to the electrodes 1018,to control the delivery of medication 1017. These output signals mightbe pulsed waveforms intended to switch the compressor and valves on andoff, or to induce electroporation, or they may be analog voltage signalsintended to set the compressor speed. The SCCE 1030 also receivessignals from the transducers 1031, e.g. pressure transducer,displacement transducers and thermal transducer. These received signalsmight be pulsed waveforms, or analog voltage levels as output from therespective types of transducers 1031.

Additionally, the SCCE 1030 may perform communications via thecommunications provider 1070, typically with a therapy provider 1042.Thus, the therapy provider 1042 may be located at another location thanthe patient 1020. Advantageously, the patient 1020 may operate themonitored therapy system 1000 at home and be simultaneously monitored bythe therapy provider 1042. Thus, a service provider 1040 can sendsignals to the SCCE 1030 via the communications provider 1070 to controlor set the parameters of the patient's 1020 session in accordance with atherapy plan, or in response to the measurements. Advantageously, theproviders can see the results of the session and provide diagnostics,advice, or make therapeutic changes to further enhance the therapy, froma remote location. Furthermore, a provider computer (in addition to orinstead of the SCCE 1030) may also be capable of translating the signalsoutput from the transducers into the appropriate measurements ofdisplacement, work, pressure or force, and the number and speed ofrepetitions. Advantageously, the monitored therapy system provides asystem that other members, such as advice providers 1043 or financingproviders 1060 could connect to and interact with. Thus, a financingprovider 1060 can monitor, or verify that therapy session data wasstored (and can be later retrieved), to facilitate the immediatetransfer of funds to the service provider's 1040 account (not shown).Monitoring and storage and systems are well known and commerciallyavailable from Nice Systems, Motorola, Diebold, or Logitech. Storage,search, and retrieval systems for complex databases are commerciallyavailable from Teradata or TRW. Knowing that the therapy session hasbeen electronically stored, a financing provider 1060 can recommendimmediate incentives (not shown) such as discounts to encourage memberswho reduce facility and transportation costs by participating inremotely monitored therapy. Such stored session information is alsouseful as unambiguous evidence that can help reduce costs for legalservices, and help amicably settle disputes.

The SCCE 1030 will comprise many different circuits including: pulsewidth modulation circuits that will generate a pulsatile waveform tocontrol medication delivery and pressure, digital to analog circuits tocreate a variable voltage level to adjust the compressor speed; drivercircuits to convert the outputs from the pulse width modulator and thedigital to analog circuit into the proper voltage and current to supplythe valves and the compressor; transceiver circuits to convert thepulsed waveform from the displacement transducers into a computerreadable form; analog to digital circuits to convert the signals fromthe displacement transducers, temperature sensors, and pressuretransducers into computer readable form; and also data communicationcircuits such as a modem, Ethernet transceiver, USB transceiver,infrared or RF transceivers, or a simple serial interface to allowconnection to the computer (e.g. the therapist's computer if it islocated nearby). These circuits are commercially available asadd-on-boards for personal computers through companies like NationalInstruments located in Austin, Tex. They are also readily constructedfrom available components from electronics components made bymanufacturers like Texas Instruments (located in Dallas, Tex.) andNational Semiconductor (located in Santa Clara, Calif.), availablethrough distributors and catalog sources like DigiKey and NewarkElectronics. The circuits themselves are well-understood and aredescribed in readily available reference books.

The pneumatics/fluidics module 1014 receives signals from the SCCE 1030,either generated by the therapy provider 1042 or the patient 1020, toregulate the air or fluids going into and out of the compressiblesubstance 1012. Thus, the SCCE 1030 sends the appropriate signals tomake sure the pressure within the compressible substance is as desired.Again, as described above, the pneumatics/fluidics module may comprisean electronically controlled compressor (or pump) and/or valves. Thecompressible substance 1012 is also as described above and includes aflexible enclosure containing one or more chambers within thecompressible substance 1012. The compressor and/or valves (of thepneumatics/fluidics module 1036) would be connected to the fill tubesleading to each chamber, to establish air or fluid pressure in eachchamber and to regulate the flow in and out of each chamber. Thetransducers 1031, provide the measurements in the form of signals sothat determinations of motion, force while squeezing the compressiblesubstance, a calorimetric estimate of the work done can be obtained bythe SCCE 1030, along with the number and speed of repetitions.

The patient 1020 wears the therapy device 1010 and interacts with thecompressible substance 1012 and elastic members 1016. The system mayinclude medication 1017 and electrodes 1018 on the interior surface ofthe glove 1019. The electrodes 1018 are linked to the SCCE 1030 tomonitor and control the transdermal delivery of the medication 1017.Precise estimates of drug absorption can be transmitted and displayedfor the patient 1020 on the display 1039, or for a provider. If analysisof variables such as duration, number of repetitions, medicationconcentration, electrode activity, temperature or other measurementsindicate an anomaly, then alarms can be displayed and the therapyparameters appropriately adjusted. A skilled artist could easily alterthis embodiment by swapping or positioning sensors, or transducermodules, in various locations without departing from the spirit of theinvention.

Referring next to FIG. 11, a functional block diagram is shown oftherapy system 1100 that uses a glove embodiment, as described abovewith reference to FIGS. 6 through 9B. The therapy system 1100 includesthe therapist/patient 1102, computer 1104, computer link 1106,controller 1108, glove 1110, and the hand 1112. The controller 1108includes a control panel 1114, feedback controller 1116, andinput/output 1118 (also referred to as IO 1118). The glove 1110 includesa pneumatics/fluidics module 1120, the compressible substance 1122, andtransducers 1124. The therapist/patient block 1102 is coupled to thecomputer 1104 and control panel 1114 of the controller 1108. The controlpanel 1108 is coupled to the feedback controller 1116 of the controller1108 which is coupled to the input/output 1118 (IO) of the controller1108. The computer 1104 is coupled to the IO 1118 of the controller 1108via the computer link 1106. Furthermore, the IO 1118 of the controller1108 is coupled to the pneumatics/fluidics module 1120 of the glove1110, which is coupled to the compressible substance 1122 of the glove.The transducers 1124 are coupled back to the IO 1118 of the controller1108. The hand 1112 of the patient interacts with compressible substance1122 and the transducers 1124 of the glove 1110.

In operation, the hand therapy system works 1100 with the glove 1110 toprovide a means for measuring the motion, force and work done by thepatient 1110. Furthermore, it provides a means for controlling thepressure resistance of the compressible substance 1122 of the glove 1110automatically, so that therapy parameters can be set and maintainedautomatically by the patient's or therapist's interaction with thecontroller 1108.

The therapist/patient block 1102 represents both the patient and thetherapist. As shown in this embodiment, both the patient and thetherapist have access to the measurements obtained using the glove 1110in addition to being the operators of the hand therapy system 1100. Boththe patient and the therapist can set the therapy parameters such asresistance pressure (of the compressible substance 1122), and willreview the therapy outcomes such as joint movement, pressure or forceapplied, and work done. Over time, the therapist will adjust the therapyparameters to reflect the best plan of treatment. The therapist mayinteract with the hand therapy system 1100 directly through the computer1104 or remotely over a computer network via the computer link 1106,such as the Internet link. The computer 1104 is either physicallyintegrated with the controller 1108 in a monolithic enclosure, locatedin the vicinity of the controller 1108, or connected to the controller1108 via a computer network (e.g. the internet) through the computerlink 1106 (e.g. an internet link). It provides a readily accessible wayfor the therapist to adjust parameters and review treatment, locally andremotely. The computer 1104 stores and organizes therapy parameters andoutcomes in a database for archival and ready access. It also convertsoutcomes data into a graphical charts displayable on a computer terminaland printable on paper that ease the interpretation of the outcomes dataand help the therapist make better decisions.

The controller 1108 is the electronic brain of the hand therapy system1100. It might be a standalone unit, located near the patient, or itmight be a miniature battery operated controller that is integrated ontothe glove (e.g. as an attachment to the compressor/pressure transducermodule or the displacement transducer module). The controller 1108receives signals from the transducers 1124 of the glove representingfinger displacement (from the displacement transducers), force applied(from the pressure transducers) and work (measured as a calorimetricestimate from the thermal transducer) and contains the algorithmsnecessary to translate the signals from the various transducers into therespective estimations of the finger displacement, temperature and forceor pressure applied. The controller also sends control signals to thecompressor (within the pneumatic/fluidics module 1120) of the glove toset the glove's resistance (e.g. the compressor and valve settings). Thecontroller 1108 contains an embedded computer that manages theactivities of the controller, translates the signals from thetransducers, and maintains communications between the controller 1108,the glove 1110, and its users. It could be a custom computer, or be acommon personal computer running commercially available software, suchas National Instruments' Labview.

The controller 1108 is comprised of the subsystems of the feedbackcontroller 1116, control panel 1114 and the IO 1118. The control panel1114 consists of knobs, buttons and displays that allow the user to settherapy parameters and review therapy outcomes.

Theses knobs, buttons and displays are electronically connected to thecontroller's 1108 embedded computer. The control panel 1114 may beconfigured so that the user can: set the initial and final pressureresistance level of the compressible substance 1122 within the glove;set a repetitions counter or therapy timer; set limits and alarms forexcess pressure or other abnormal conditions; set control parameters forthe feedback controller 1116, such as PID (proportional, integral,derivative) constants; store parameters for future use; and control thepower to the controller 1108.

Additionally, the control panel 1114 may provide a display indicatingreal time indications of pressure, displacement, and work in aggregateor on a finger by finger basis, as well as graphical displays of suchmeasurements. Additionally, the glove settings may be shown. Suchdisplays may be displayed on a corresponding computer or on a screen ordisplay of the controller itself depending on the embodiment.

The feedback controller 1116 allows the pressure resistance of thecompressible substance 1122 to be adjusted automatically in dynamicresponse to predetermined pressure profiles and sequences, existingpressure in the chamber/s of the compressible substance 1122, fingermotion, and the work being done. The feedback controller 1116 is afunction performed by the controller's embedded computer. It receivesthe real-time pressure, displacement, and work measurements, then usesreadily available algorithms, such as PID (proportional, integral,derivative) control to send the proper signals to adjust the valvesettings and the compressor (within the pneumatics/fluidics module1120), to maintain the pressure resistance within the chamber/s of theglove 1110 according to the user's settings. The feedback controller1116 contains therapy data storage circuits, parameter storage circuits,and a real time clock that permit it to operate autonomously.

The IO 1118 allows the controller 1108 to communicate with the glove1110 and the computer 1104. The IO 1118 outputs signals to thepneumatic/fluidic module 1120, which contains the compressor and thevalves, to control the amount of pressure that the chambers are inflatedor filled up to in order to provide the appropriate resistance when thepatient squeezes the compressible substance 1122. These output signalsmight be pulsed waveforms intended to switch the compressor and valveson and off, or they may be analog voltage signals intended to set thecompressor speed. The IO 1118 also receives signals from the transducers1124, e.g. pressure transducer, displacement transducers and thermaltransducer. These received signals might be pulsed waveforms, or analogvoltage levels as output from the respective types of transducers 1124.

Additionally, the IO 1118 may perform data communications with thecomputer 1104 via the computer link 1106. The computer 1104 is typicallythe therapist's computer, which may be physically attached to thecontroller 1108 through serial interfaces or may be linked via acomputer link 1106 to the controller. The computer 1104 may be part of alocal area network or wide area network or other computer network. Thus,the therapist may be located at another location than the patient.Advantageously, the patient may operate the hand therapy system 1100 athome and be simultaneously monitored by the therapist online with thecontroller 1108. Thus, the therapist can send signals from thetherapists computer 1104 to the controller 1108 via the computer link1106 (such as an internet link) to control or set the parameters of thepatient's session in response to the measurements of the glove 1110.Advantageously, the therapist can see the results of the session (i.e.the estimations of finger displacement, work, force or pressure, and thenumber and speed of repetitions) and recommend desired changes tofurther facilitate improve in a patient's condition without having to bephysically present at the session. Furthermore, the computer 1104 (inaddition to or instead of the controller 1108) may also be capable oftranslating the signals output from the transducers into the appropriatemeasurements of displacement, work, pressure or force, and the numberand speed of repetitions.

The IO 1118 will comprise many different circuits including: pulse widthmodulation circuits that will generate a pulsatile waveform to controlthe compressor and valves of the pneumatics/fluidics module 1120;digital to analog circuits to create a variable voltage level to adjustthe compressor speed; driver circuits to convert the outputs from thepulse width modulator and the digital to analog circuit into the propervoltage and current to supply the valves and the compressor; transceivercircuits to convert the pulsed waveform from the displacementtransducers into a computer readable form; analog to digital circuits toconvert the signals from the displacement transducers, temperaturesensors, and pressure transducers into computer readable form; and alsodata communication circuits such as a modem, Ethernet transceiver, USBtransceiver, infrared or RF transceivers, or a simple serial interfaceto allow connection to the computer (e.g. the therapist's computer if itis located near the IO 1118).

The glove 1110 comprises the pneumatics/fluidics module 1120, thecompressible substance 1122, and the transducers 1124. Thepneumatics/fluidics module 1120 contains the compressor and appropriatevalves of the compressor/pressure transducer module described earlier.The pneumatics/fluidics module 1120 receives signals from the controller1108, either generated by the therapist or the patient, to regulate theair or fluids going into and out of the compressible substance 1122.Thus, the controller 1108 sends the appropriate signals to make sure thepressure within the compressible substance is as desired. Again, asdescribed above, the pneumatics/fluidics module may comprise anelectronically controlled compressor (or pump) and/or valves.

The compressible substance 1122 is also as described above and includesa flexible enclosure containing one or more chambers within thecompressible substance 1122. The multi-chamber compressible substance asshown in FIGS. 7A through 8 would permit resistance pressure regulationon a finger-by-finger basis, whereas a single chamber, such as shown inFIG. 6, would be a simpler way to regulate the pressure resistance ofall the fingers together. The compressor and/or valves (of thepneumatics/fluidics module 1120) would be connected to the fill tubesleading to each chamber, to establish air or fluid pressure in eachchamber and to regulate the flow in and out of each chamber.

The transducers 1124, as described above as the pressure transducer, thedisplacement transducer, and the thermal transducer, provide themeasurements in the form of signals back to the controller 1108 so thatdeterminations of finger motion, force exerted by each finger or thehand total while squeezing the compressible substance, a calorimetricestimate of the work done can be obtained by the controller 1108, andthe number and speed of repetitions.

The patient's hand 1112 fits within the glove 1110 and interacts withthe compressible substance 1122. The glove 1110 is designed to snuglyfit the patient's hand 1112 and contains the transducers 1124 requiredto obtain the measurements. Additionally, the glove may be embodied asdescribed above, including the addition of medication on the interiorsurface of the glove 1110. The glove 1110 will fit properly to thepatient's hand 1112 and will provide resistance to motion that istherapeutically appropriate. Furthermore, the glove 1110 will positionand anchor the transducers 1124 and compressible substance 1122 so thatthe measurements are sufficiently accurate and precise.

Referring next to FIG. 12, a view is shown of the details of thecompressor/pressure transducer module described above. Shown are a glove1200, compressible substance 1202, first tube 1204, and thecompressor/pressure transducer module 1206. The compressor/pressuretransducer module 1206 includes a first tee 1208, second tee 1210, ventsolenoid 1212 (also referred to as the vent valve), pump solenoid 1214(also referred to as the pump or compressor valve), pressure transducer1216, compressor 1218, filters 1220 and 1221, tubes 1222, 1224, 1226,1228, 1230, 1232, and 1234, wires 1236, 1238, 1240 and 1242, theinterface port 1244, and the interface means 1246. The first tube 1204enters the compressor/transducer module 1206 and is coupled to the firsttee 1208. The vent solenoid 1212 is coupled to the first tee 1208 viatube 1222 and is also coupled to filter 1220 via tube 1224. Tube 1226couples the first tee 1208 to the second tee 1210. The second tee iscoupled to the pressure transducer 1216 via tube 1228 and the pumpsolenoid 1214 via tube 1230. The pump solenoid 1214 is coupled to thecompressor 1218 via tube 1232. The compressor 1218 is coupled to thefilter 1221 via tube 1234. Wire 1236 is coupled from the vent solenoid1212 to the interface port 1244, wire 1238 is coupled from the pressuretransducer 1216 to the interface port 1244, wire 1240 is coupled fromthe pump solenoid to the interface port 1244, and wire 1242 is coupledfrom the compressor 1218 to the interface port 1244. The interface means1246 links to the interface port 1244 and is the input to a computersystem, e.g. the SCCE of FIG. 10.

In practice, the compressor/transducer module 1206 pumps materials, suchas gas, air, fluids, or gels into the chamber or chambers (not shown) ofthe compressible substance 1202 and provides the means for measuring theforce exerted by the fingers (i.e. fingers and thumb) of the patient'shand upon squeezing the compressible substance 1202. The embodimentshown in FIG. 12 inflates the chamber/s of the compressible substance,1202 with air or another similar gas.

In order to inflate the chamber/s within the compressible substance1202, the compressor 1218 pulls air through the filter 1221 via tube1234 and forces the air out through tube 1232. The compressor, which isa miniature mechanical compressor as described above with reference toFIG. 6, e.g. rotary vane pump, is controlled or activated by controlsignals sent through wire 1242. Furthermore, the compressor 1218 may bereversible, such that it may assist in the deflation of the compressiblesubstance 1202. The pump solenoid 1214 acts as a valve and controls theflow of air into the rest of the system. Typically, the pump solenoid1214 (controlled by signal sent via wire 1240) works in concert with thecompressor 1218, such that when the compressor is “pumping” to inflatethe chambers within the compressible substance 1202, the pump solenoid1214 is open to allow the compressor 1218 to force the air therethrough.Alternatively, pinch valves may be used instead of the solenoids asdescribed above with reference to FIG. 6. The air is pumped through tube1230 and through the second tee 1210 into tube 1226 and the first tee1208. The air continues through the first tee 1208 and into the firsttube 1204 which is fed into the chambers of the compressible substance1202 in order to inflate the chambers to a desired pressure level.

Air is also pumped into tube 1222 from the first tee 1208 to the ventsolenoid 1212, which acts as a valve; however, during the “pumping” ofthe compressor 1218, the vent solenoid 1212 is closed such that the airwill not be allowed to flow through the vent solenoid 1212. The ventsolenoid 1212 is controlled via signals sent through wire 1236.

Furthermore, air is forced against the port of the pressure transducer1216 through tube 1228 of the second tee. The pressure transducer 1216of the compressor/pressure transducer module 1206 is a transducer thatproduces a signal, such as a voltage proportional to the pressureapplied to its port. The pressure transducer 1216 is used duringinflation to determine when the desired pressure (e.g. desired psi)within the compressible substance 1202 has been reached. Wire 1238 ofthe pressure transducer 1216 transmits the voltage signals proportionalto the pressure within tube 1228 to the controlling computer (totranslate the signals into estimation of pressure) through the interfaceport 1244 and the interface means 1246. Such information is used tocontrol the switching on and off of the compressor 1218. The compressor1218 is well known in the art as described with reference to FIG. 6.

Once the pressure within the chambers of the compressible substance 1202is at the desired level, i.e. the pressure at the pressure transducer1216 is at the desired level, the pump solenoid 1210 is closed and thepatient squeezes the compressible substance 1202, which forces air backinto the first tube 1204 and causes more pressure to be placed upon thepressure transducer 1216. Thus, the pressure transducer 1216 sendsvoltage signals which are proportional to the additional pressure withinthe system, which can be translated, by the controller of FIG. 10 forexample, into the pressure or force exerted by the digits of the hand(e.g. by taking the difference between the initial pressure and theadditional pressure), either collectively, or individually, depending onthe embodiment. There is typically a direct proportionality between theforce or pressure applied by the fingers and the measurements of thepressure transducer; however, this proportionality may be altered bydifferent configurations and different material selection.

Additionally, the vent solenoid 1212 may be employed to vent the system;thus, allowing rapid deflation of the compressible substance 1202 uponcompletion of the therapy. In this case, the vent solenoid 1212 isopened, while the pump solenoid 1214 is closed. Thus, the air containedwithin the compressible substance 1202 and the system will be pushed outthrough tube 1222, through the vent solenoid 1212, through tube 1224,and out of the compressor/transducer module 1206 through filter 1220.

The compressor/pressure transducer module 1206 may be as shown, i.e. asa separate unit not physically located on the body of the glove. Thus,the compressor/pressure transducer module 1206 may be worn on the bodyof the patient (e.g. on the patient's belt) or placed nearby the patientand attached to the compressible substance 1202 via the first tube 1204.Alternatively, the compressor/pressure transducer module 1206 may beintegrated onto the body of the glove, as described above with referenceto FIG. 6. The components of such a module are well known in the art;thus, no further explanation is required. Furthermore, thecompressor/pressure transducer module 1206 may be easily modified topump fluids or other gases into the compressible substance 1202 byattaching gas canisters or fluid reservoirs at the locations of thefilters 1220 and 1221, for example (see FIG. 3).

Furthermore, for a compressible substance 1202 including more than onechamber, e.g. one chamber for each finger, there are five separatepressure transducers 1216 within five separate compressor/pressuretransducer modules 1206. Thus, there is one compressor/pressuretransducer module 1206 for each respective chamber of the compressiblesubstance 1202. Alternatively, there may be one compressor/pressuretransducer module, including 5 pressure transducers all sharing the samecompressor and/or sharing common vent solenoids.

Referring next to FIG. 13 is a flowchart showing the steps for providinginformation useful to offer targeted incentives. The system providesdiagnostic information (step 1302); which is useful for generatingtherapy plan information (step 1304); which is useful for gainingpatient approval information (step 1306); all of which information isuseful for obtaining financing provider approval and incentiveinformation (steps 1308, 1310). The product and advice providers accessthe therapy plan information (step 1312) which is useful foradvertising, promoting, proposing, or bidding (step 1314). Advertisingprovides product knowledge and substantial revenue. This step providestargeted information to members based on estimates of their needs. Thiscompetitive bidding process is useful for providing savings. The patientand provider accept offers (step 1316) and this information is usefulfor transferring funds (step 1318) from the financing provider to theproduct and service providers. The funds transfer information is usefulfor prompting the delivery of products and services (step 1320). Thetherapy session (step 1322) information is useful for monitoring andcontrolling the therapy (step 1324). This information is stored (alsostep 1324) and is useful for updating diagnostics (step 1302).

Referring back to step 1310, when the financing provider offersincentives: there is an unmet need for incentives for protecting fundsmanaged by healthcare financing providers, such as Medicare. Forexample, Medicare funds might be readily available for limosine or airtravel for non-emergency therapy sessions, without any incentive to saveby choosing remotely monitored home therapy. Other questionable factorsthat providers employ include items such as broadcast advertising, orlegal expenses for unsafe pills. For example, recent broadcasttelevision ads promote motorized scooters that can be financed byMedicare; with company sales reps ready to assist with Medicareprocessing. Thus, questionable items, such as broadcast advertising andsales commissions, are passed through to the Medicare members in higherscooter prices. Restated with reference to FIG. 10, financing providers1060, such as Medicare 1062, are paying for factors employed by productproviders 1050, such as equipment providers 1054, who employ broadcastadvertising 1046, and Medicare processing advice 1044, which increasesthe prices Medicare 1062 and patients 1020 pay for equipment. Thus,Medicare trustees need improved processing systems, and incentives toencourage members to protect the fund. In the above example, anequipment provider could simply access the system (step 1312) to targetpatients with diagnostic data that indicate potential need for theirequipment, and use the system to send advertising information (step1314) directly to those patients. Instead of paying Medicare processingcommissions, the patient can simply use the system to efficiently updateor fill in the appropriate Medicare data fields online. If targetedadvertising and automatic processing reduce costs, then Medicare canoffer incentives to patients and providers who choose (step 1316)methods that effect those savings. Thus performance can be tracked andrewarded based on individual transactions, or perhaps by tiered orcertification programs, whereby providers can be rewarded. Incentivesystems are known in the art, such as U.S. Pat. No. 6,434,534, issuedAug. 13, 2002 to Walker, et al. entitled “METHOD AND SYSTEM FORPROCESSING CUSTOMIZED REWARD OFFERS”, and U.S. Pat. No. 5,689,100 issuedNov. 18, 1997 to Carrithers, et al. entitled “DEBIT CARD SYSTEM ANDMETHOD FOR IMPLEMENTING INCENTIVE AWARD PROGRAM” (both of which areincorporated herein by reference). The U.S. Pat. No. 5,689,100 patent isassigned to Maritz, Inc. of Fenton, Mo. whose methods and systems formanaging incentive programs are commercially available, so Medicarewould not need to manage the incentive program directly. Furthermore,Medicare members may lobby for macroincentives, such as tax exemptions;research grants; tiered levels of antitrust exemptions; investmenttrusts; securities; interstate licensing; targeted advertising lists; oraccess to foreign membership. Thus, providers who implement systems thatprotect (or grow) the Medicare fund can be rewarded with strategicincentives. Most conventional theories would object to early incentives,such as using diagnostic information from a therapy system to generatetargeted advertising. It is obvious that this is a violation of privacylaws. Thus, conventional theory would reject proposals to use a therapysystem to provide targeted advertising that generates a profit, or atleast reduces broadcast advertising passthrough cost. But, U.S. Pat. No.6,285,983 issued Sep. 4, 2001 to Jenkins entitled “MARKETING SYSTEMS ANDMETHODS THAT PRESERVE CONSUMER PRIVACY” (which is incorporated herein byreference) teaches a targeted advertising system that can protectprivacy through a third party repository. And U.S. Pat. No. 6,334,110issued Dec. 25, 2001 to Walter, et al. entitled “SYSTEM AND METHOD FORANALYZING CUSTOMER TRANSACTIONS AND INTERACTIONS” (which is incorporatedherein by reference) teaches how to extract targeted information fromthe therapy system in a timely manner, so incentives or rewards can beoffered early in the process.

Referring to FIG. 14 is a view an embodiment of means for monitoring thetherapy system. The screen display 1400 receives and displaysinformation from the controller 1402. The controller 1402 receivesinformation from the patient. In this instance, the patient positions amember incentive card 1404 so as to be readable by the controller 1402.Information from the card is transmitted, received, and displayed formembers of the system who can help meet the patient's needs, such as(referring back to FIG. 10) the financing provider 1060, serviceprovider 1040, or product provider 1050. In this embodiment, theincentive card 1404, provides markings that verify that the patient is amember of a remote monitoring plan. Thus the identification,authorization, pricing, therapy session, and payment processes areremote and automatic, so the therapy session can commence in a timelymanner. If problems arise, the stored session records can be retrieved,and reviewed; providing evidence useful for legal expense savings. U.S.Pat. No. 6,442,532 issued Aug. 27, 2002 to Kawan entitled “WIRELESSTRANSACTION AND INFORMATION SYSTEM”, U.S. Pat. No. 7,040,533 issued May9, 2006 to Ramachandran entitled “CASH WITHDRAWAL FROM ATM VIAVIEDOPHONE”, and U.S. Pat. No. 6,385,595 issued May 7, 2002 to Kollinget al. (all of which are incorporated herein by reference) teach relatedmethods and systems.

Referring next to FIG. 15 is a screen display view of remote therapy inoperation. A side window 1502 displays therapy related information; inthis view the therapist is speaking to the patient. Content topics ormenus 1504 provide means for choosing therapy related information.Buttons let the patient start as new session 1506; save a session 1508;send a stored session as an email attachment 1510; review a previoussession 1512; or review therapy progress 1514. The main window 1516displays content such as a therapy session in progress. U.S. Pat. No.6,813,372 issued Nov. 2, 2004 to Standridge et al, entitled “MOTION ANDAUDIO DETECTION BASED WEBCAMMING AND BANDWIDTH CONTROL” (which isincorporated herein by reference) teaches a system for transmitting andreceiving signals to generate such a display under low bandwidth or lowmemory conditions. U.S. Pat. No. 6,173,317 issued Jan. 9, 2001 toChadda, et al. entitled “STREAMING AND DISPLAYING A VIDEO STREAM WITHSYNCHRONIZED ANNOTATIONS OVER A COMPUTER NETWORK” (which is incorporatedherein by reference) teaches a system for providing such a display underhigher bandwidth and higher memory conditions. Alternatively, the mainwindow 1516 could display training or research information; andpreviously stored therapy sessions could be used for research studies,or licensed as content for such training sessions.

FIG. 16 is another embodiment of a screen display of a remote therapysession in operation. A side window 1602 displays performance metrics.The internet address 1604 shows a link whereby the patient, therapist,and other providers can obtain access to help meet the patient's needs,depending on levels of permission. The main window title bar 1606displays information about the patient and the therapy session, alongwith information about the incentive level. The main window 1608,displays a therapy session in progress, preferably, in real time. U.S.Pat. No. 7,130,618 issued Oct. 31, 2006 to Hirotugu, entitled “METHODS,APPARATUS, AND SYSTEM FOR TRANSMITTING MOVING IMAGE DATA” (which isincorporated herein by reference) teaches modern means for monitoringtherapy. Information from the therapy is transmitted, received, anddisplayed for members of the system who can then make customizedrecommendations, based on the collected therapy information, to helpmeet that patient's specific needs.

While the invention herein disclosed has been described by means ofspecific embodiments and applications thereof, numerous modificationsand variations could be made thereto by those skilled in the art withoutdeparting from the scope of the invention set forth in the claims.

1. An therapy system comprising: a product worn by a person, saidproduct including a compressible substance affixed thereto, saidcompressible substance being located proximate to a joint of saidperson, said compressible substance providing resistance against flexionof said joint, during the active flexion movements of said person,wherein said compressible substance may be squeezed between bonesbrought together during the flexion of said joint, wherein massaging thebody tissues between said compressible substance and the convergingbones; and stretchable fabric, said fabric having elastic properties,wherein said fabric is attached to the product, and extending outwardlytherefrom, and spanning to the compressible substance, and coupledthereto, said fabric providing resistance against extension of saidjoint, during the active extension movements of said person, whereinsaid fabric, when stretched between bones brought farther apart duringthe extension of said joint, may urge said product to press against saidperson, wherein massaging the body tissues under the pressure; andattachment means, whereby said compressible substance and said fabricmay be affixed to said product.
 2. The system of claim 1 furthercomprising means for monitoring said therapy.
 3. The system of claim 1further comprising means for controlling said therapy.
 4. The system ofclaim 1 wherein said product further comprises means for regulatingpressure, wherein a therapeutic gas, fluid, gel, or ingredient mayenter, exit, be retained, be extracted, be flow-regulated, or beflow-restricted.
 5. The system of claim 1 wherein said product containsone or more therapeutic ingredients, such as a medication, supplement,gene, transdermal or transcellular carrier agent.
 6. The system of claim5 further comprising means for monitoring said therapy.
 7. The system ofclaim 5 further comprising means for controlling the delivery of saidtherapy.
 8. A therapy system comprising: an exercise device worn on anextremity of a person comprising: a resilient compressible substancepositioned in close proximity to a joint of said extremity, saidcompressible substance providing resistance against flexion of saidjoint, wherein said compressible substance is squeezed between theextremity portions that converge during the active flexion movements ofsaid person; and at least one base fabric portion for engaging one ormore portions of said extremity; and one or more elastic fabricportions, said elastic fabric coupled to said compressible substance andextending outwardly therefrom, and spanning to one or more of said basefabric portions, and attached thereto, said elastic fabric providingresistance against the extension of said joint, during the activeextension movements of said person; and attachment means, whereby thebase fabric may be affixed to the elastic fabric.
 9. The system of claim8 further comprising a circuitry module linked thereto, said circuitrymodule including means for providing a signal proportional to aperformance parameter.
 10. The system of claim 8 further comprisingdisplay means, for displaying performance information, wherebyfacilitating the communication of performance information to a personmonitoring the performance.
 11. The system of claim 8 further comprisingmeans for communicating with a processing system, whereby saidprocessing system may determine performance information.
 12. The systemof claim 11 further comprising networking means, wherein saidperformance information adapted to being communicated, processed,stored, or displayed over a network.
 13. The device of claim 8 furthercomprising a gas, fluid, gel, or therapeutic ingredient containedtherein.
 14. The system of claim 13 further comprising pressureregulating means connected thereto.
 15. The system of claim 13 furthercomprising means for monitoring said therapy.
 16. The system of claim 15further comprising means for controlling said therapy.
 17. The device ofclaim 15 further comprising means for storing therapy information. 18.The device of claim 15 further comprising means for communicatingtherapy information.
 19. A monitoring system for monitoring one or moretherapy systems, said monitoring system comprising: means for collectingtherapy information from said therapy system; and means for determiningperformance information from said therapy system information, wherein aprovider determines a customized recommendation based on saidperformance information.
 20. The monitoring system of claim 20 whereinsaid customized recommendation further comprises a therapy productrecommendation.
 21. The monitoring system of claim 20 wherein saidcustomized recommendation further comprises a customized incentiverecommendation.